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To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral or nasal endotracheal intubation | Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirWave | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis. | 24 hours |
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Inclusion Criteria
Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria:
Exclusion Criteria
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MICU Based
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| Name | Affiliation | Role |
|---|---|---|
| Adriano Tonelli, MD | The Cleveland Clinic Foundatin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Inclusion Criteria: subjects were eligible for the study if they met all of the following criteria: (1) age > 18 years old; (2) oral endotracheal intubation within 24 hours of recruitment; (3) expected duration of mechanical ventilation > 24 hours; (4) ETT internal diameter sizes from 6.5 to 9.0 mm. Exclusion criteria: subjects were excluded from participation if (1) ventilated through a tracheostomy, (2) unable to obtain consent, or (3) pregnancy.
During the study period, 42 patients were enrolled. Subjects had the AirWave system placed within 24 hours of endotracheal intubation. A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral or Nasal Endotracheal Intubation | Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. AirWave Migration at 24 hours as determined by (a) portable CXR (n = 28) was -0.06 (±1.3) cm with range of -3.5 and +3 cm, (b) ETT distance at the lips (n = 38) was -0.29 (±0.93) with a range of -2 to +3, and (c) the AirWave system (n = 27) was 0.39 (±1.5) with a range of -3 to +4 cm. Diverse reasons (Fig. 2) reduced the total number of patients in whom these three techniques can be compared. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | (ETT) Migration During Routine Care Among Critically Ill Patients | A total of 42 patients (age: 61 [SD ±13] years, men: 52%) were recruited. A total of 19 patients had measurements of ETT migration at 24 hours by the 3 methodologies used in this study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis. | A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study. | Posted | Mean | Standard Deviation | cm | 24 hours |
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24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral or Nasal Endotracheal Intubation | Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. AirWave |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adriano Tonelli, MD | Cleveland Clinic Foundation | 216-444-0812 | tonella@ccf.org |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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